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510(k) Data Aggregation

    K Number
    K250894
    Manufacturer
    Date Cleared
    2025-10-07

    (196 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Eminent Spine Posterior SI System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

    Device Description

    The Eminent Spine Posterior SI System is inserted through an SI posterior approach and packed with autogenous bone graft to facilitate fusion. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device and to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation, adding compression and transfixation in the SI joint. The device is intended to provide mechanical support to the implanted level until fusion is achieved.

    The cages are made from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6Al-4V ELI per ASTM F136.

    The SI posterior system cages are available in one footprint with a lordotic angle. The anterior face of the cage has one screw anti-backout plate that rotates to cover the screw heads and prevent the screws from backing out of the cage after insertion. The screws are available in two diameters (Ø3.50mm, Ø3.75mm), in lengths ranging from 10-18 mm. The screws are positioned to span and compress the cortices of the ilium and sacrum of the SI joint.

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